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Avandia Rejected in Germany

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Frankfurt, GermanyHealth insurers have been told to stop paying for Avandia, according to a 6/18/10 Reuters report. Meanwhile, the US Food and Drug Administration (FDA) prepares to hold an advisory conference concerning the risks associated with Avandia side effects.

Germany's Federal Joint Committee of doctors and health insurers has recommended that insurers stop paying for Avandia, made by GlaxoSmithKline, due to the risk of heart problems and bone fracture associated with the diabetes medication. The committee's recommendations are reportedly widely followed.

The Federal Joint Committee's chairman, Rainer Hess, noted in a statement that there are other medications that do not have the same side effects or long-term risks as Avandia and called for patients to be protected against "useless and, more importantly, harmful therapies." GlaxoSmithKline defended its drug, saying, "The committee's course of action is not justified neither from a medical, nor legal point of view."

Avandia is not the only medication affected by the recommendations. Actos, made by Takeda, is included in the recommendations.

Meanwhile, an unpublished study by FDA drug safety official David Graham alleges that Medicare patients suffered up to 48,000 heart attacks, strokes and other Avandia side effects, which could have been avoided if those patients had taken other medications. Although the study is unpublished, an FDA official said data from that study would be included in next month's Avandia safety review.

Graham has said he would like to submit the study to the Journal of the American Medical Association. An e-mail that accompanied the study, posted by the Pharmalot blog, accused FDA officials of delaying his study from being published. The Journal of the American Medical Association neither confirms nor denies receipt of any manuscript until it is published.

The FDA has acknowledged the legitimacy of the study, which reportedly found that patients who took Avandia suffered a 27 percent greater risk of stroke, 25 percent greater risk of heart failure and a 13 percent greater risk of death than patients taking other medications.

GlaxoSmithKline noted that it is premature to comment on the study and cited "inherent limitations" in such studies as Graham's. The drugmaker also cited results from six clinical trials that did not show an increase in the risk of heart attack, stroke or death.

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